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Treatment Name: Alectinib (Alecensa®)

Alectinib (Alecensa®) is a Treatment Regimen for Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)

How does alectinib work?
Alectinib is designed to bind to and block the function of a mutated protein called “anaplastic lymphoma kinase” (ALK) present in cancer cells. The mutated ALK protein causes the cancer cell to grow and divide more rapidly and to survive longer. Approximately 2% to 7% of patients with NSCLC have this mutation. By blocking the function of the abnormally active ALK protein, alectinib slows the growth of the cancer and causes some of the cancer cells to die.

Goals of therapy:
Alectinib is given to patients to slow the progression and to stop the spreading of lung cancer and is not currently given with the goal of cure.

Schedule

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  • Usual starting dose: 600 mg (four 150 mg capsules) by mouth twice daily with food

Alectinib is usually taken at home and is continued until it no longer works or until unacceptable side effects occur.

Side Effects

In clinical studies, the most commonly reported alectinib (Alecensa®) side effects of are shown here. Side effects sometimes have percentage ranges [example: 33 – 36%] because they differed between clinical studies:

  • Constipation (33-36%)
  • Fatigue (26-33%)
  • Swelling in arms and legs (17-25%)
  • Muscle pain (16-24%)
  • Nausea (11-22%)
  • Headache (16-21%)
  • Diarrhea (9-21%)
  • Laboratory signs of liver injury (8-21%)
  • Low red blood cells [Anemia] (18-20%)
  • Weakness (18%)
  • Shortness of breath (13-18%)
  • Cough (14-17%)
  • Weight gain (10-16%)
  • Skin rash (12%)
  • Mouth sores (12%)
  • Trouble sleeping (12%)
  • Vomiting (6-12%)
  • Sinus infection (10%)
  • Back pain (10%)
  • Dizziness (8-10%)
  • Sensitivity to sunlight (5-10%)
  • Pain in muscles, joints, and bones (7%)
  • Low white blood cells [neutropenia] (3-4%)
  • Seizures (3%)
  • Change in taste buds (3%)
  • Stomach pain (2%)
  • Blurry vision (2%)
  • Change in vision (1%)
  • Hair loss (1%)

On average, 2-11% of patients discontinue treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
ConstipationConstipationFatigue Fatigue AnemiaAnemiaPainPainNausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair Loss

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, then every two weeks for the first 3 months of therapy, then monthly thereafter. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), CPK, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment then approximately every 6 to 9 weeks during treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue alectinib as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Alectinib may cause an increased sensitivity to sunlight. Avoid long periods of sun exposure while taking alectinib and for at least 7 days after stopping therapy. When outside, wear proper clothing to cover your skin from the sun. Use a broad spectrum sunscreen (SPF ≥ 50) to help protect against potential sunburn
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for non-small cell lung cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Alectinib (Alecensa®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Alectinib (Alecensa®). Depending upon your income, they may be able to help cover the cost of:

  • Alectinib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Alectinib (Alecensa®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Alectinib (Alecensa®)

Individual Drug Label Information

Alectinib (Alecensa®)

  • ​Is an oral capsule available in 150 mg
  • Is taken with food. Swallow capsules whole and do not open or dissolve capsules
  • Food increases absorption so it is best to take with food to increase the amount of alectinib that gets into the blood stream
  • If you miss a dose, skip that dose and take the next dose at the regularly scheduled time. Do not double your dose to make up for the missed dose
  • Store in the original container to protect from light and moisture. Do not store above 86°F
  • Dosage adjustments may be required if certain side effects occur
  • May cause fetal harm if taken while pregnant. Females should not breast feed and should use effective contraception during therapy and for one week after stopping therapy
General side effects from alectinib (Alecensa®)
  • Liver dysfunction
  • Lung injury
  • Kidney injury
  • Slow heart beat
  • Severe muscle pain
  • Constipation
  • Fatigue
  • Low red blood cells
  • Weakness
  • Swelling in arms and legs
  • Headache
  • Cough
  • Click on the alectinib (Alecensa®) package insert link below for reported side effects, possible drug interactions, and other alectinib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1) Hida T, Nokihara H, Kondo M, et al. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet. 2017;390:29-39.

2) Ou SH, Ahn JS, De Petris L, et al. Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study. J Clin Oncol 2016;34:661-668.

3) Shaw AT, Gandhi L, Gadgeel S, at al. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol. 2016;17:234-242.

4) Peters S, Camidge DR, Shaw AT, et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377:829-838.

Created: February 12, 2019 Updated: June 22, 2019

What is Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)?

What is Non-Small Cell Lung Cancer?
A disease of the tissue found in the lung.  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Known causes include smoking and exposure to environmental toxins.  The stage of NSCLC can vary at diagnosis and throughout treatment.  Stages include stage I, II, III, and IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common Starting Doses

  • Four 150 mg capsules (600 mg) by mouth twice daily, with food

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Clinical Studies

1) Hida T, Nokihara H, Kondo M, et al. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet. 2017;390:29-39.

2) Ou SH, Ahn JS, De Petris L, et al. Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study. J Clin Oncol 2016;34:661-668.

3) Shaw AT, Gandhi L, Gadgeel S, at al. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol. 2016;17:234-242.

4) Peters S, Camidge DR, Shaw AT, et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377:829-838.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is Creatine phosphokinase (CPK)?

Creatine phosphokinase (CPK) is a muscle breakdown product and can increase in the blood if the either muscle is rapidly breaking down, the kidneys are not working well, or both. An elevation well above the normal range, may suggest muscle damage